Manual interosseous device

ABSTRACT

An apparatus for penetrating the bone marrow of a bone is provided. The apparatus includes a handle having a drive shaft, a connector having a first end operable to connect to a drive shaft and a second end operable to connect to a penetrator hub and a penetrator hub having a penetrator that accesses the bone marrow.

RELATED APPLICATION

This application claims the benefit of Provisional Patent ApplicationSer. No. 60/539,171 entitled “Manual Interosseous Device” filed Jan. 26,2004.

This application claims the benefit of Provisional Patent ApplicationSer. No. 60/547,868 entitled “Impact-Driven Interosseous Needle” filedFeb. 26, 2004.

This application is a continuation-in-part application of applicationSer. No. 10/449,476 entitled “Apparatus and Method to Access BoneMarrow” filed May 30, 2003, which claims the benefit of U.S. ProvisionalPatent Application 60/384,756 filed May 31, 2002.

TECHNICAL FIELD

The present invention is related in general to a medical device toaccess bone marrow and more specifically to an apparatus and method forpenetrating a bone and inserting a penetrator or needle into associatedbone marrow.

BACKGROUND OF THE INVENTION

Every year, millions of patients are treated for life-threateningemergencies in the United States. Such emergencies include shock,trauma, cardiac arrest, drug overdoses, diabetic ketoacidosis,arrhythmias, burns, and status epilepticus just to name a few. Forexample, according to the American Heart Association, more than1,500,000 patients suffer from heart attacks (myocardial infarctions)every year, with over 500,000 of them dying from its devastatingcomplications.

An essential element for treating all such emergencies is the rapidestablishment of an intravenous (IV) line in order to administer drugsand fluids directly into the circulatory system. Whether in theambulance by paramedics, or in the emergency room by emergencyspecialists, the goal is the same—to start an IV in order to administerlife-saving drugs and fluids. To a large degree, the ability tosuccessfully treat such critical emergencies is dependent on the skilland luck of the operator in accomplishing vascular access. While it isrelatively easy to start an IV on some patients, doctors, nurses andparamedics often experience great difficulty establishing IV access inapproximately 20 percent of patients. These patients are probedrepeatedly with sharp needles in an attempt to solve this problem andmay require an invasive procedure to finally establish an intravenousroute.

A further complicating factor in achieving IV access occurs “in thefield” e.g. at the scene of an accident or during ambulance transportwhere it is difficult to see the target and excessive motion makeaccessing the venous system very difficult.

In the case of patients with chronic disease or the elderly, theavailability of easily-accessible veins may be depleted. Other patientsmay have no available IV sites due to anatomical scarcity of peripheralveins, obesity, extreme dehydration or previous IV drug use. For thesepatients, finding a suitable site for administering lifesaving drugsbecomes a monumental and frustrating task. While morbidity and mortalitystatistics are not generally available, it is known that many patientswith life-threatening emergencies have died of ensuing complicationsbecause access to the vascular system with life-saving IV therapy wasdelayed or simply not possible. For such patients, an alternativeapproach is required.

Many medical devices such as syringes, hypodermic needles, catheters, IVtubing and stop cocks may include either a pin (male) or box (female)Luer type fitting. The pin end or box end may include threads whichallow releasably engaging an associated medical device with otherequipment having a complimentary Luer type fitting. Luer typeconnections may sometimes be described as Luer slips or Luer locks. Luerslips may require a half twist of an associated collar to securelyengage a pin end and a box end with each other. A Luer lock functions byforming a watertight fit between a pin and a box when engaged and whentwisted by a half turn or more. Luer locks frequently include a threadedlocking collar on a box end which mates with ears or projections from anassociated pin end to provide a more positive, locked connection. Luerconnections generally form fluid tight seals. Some Luer connections mayinclude tapered fittings.

SUMMARY OF THE INVENTION

In accordance with teachings of the present invention, an apparatus andmethod for communicating with or accessing bone marrow of a bone areprovided. The apparatus may include a handle having a drive shaft, aconnector having a first end operable to connect to the drive shaft anda second end operable to attach to a penetrator hub. The penetrator hubmay include a penetrator operable to access the bone marrow.

In an alternate embodiment an apparatus for manually penetrating a boneand associated bone marrow is provided. The apparatus may include ahandle having at least one drive shaft, a releasable connector with afirst end operable to attach to the at least one drive shaft and asecond end operable to attach to a penetrator hub. The penetrator hubhaving a fitting operable to attach to the connector and a penetratoroperable to access the bone marrow.

In another embodiment a method of accessing bone marrow of a bone isprovided. The method may include inserting a penetrator into the bonemarrow using an apparatus having a handle, a drive shaft and a connectorwith a first end operable to connect to the drive shaft and a second endoperable to connect to a penetrator assembly. For some applications, atrocar may be disposed within the penetrator assembly. After insertingportions the penetrator assembly into the bone marrow, the handle andconnector may be detached from the penetrator assembly. The trocar, whenused, may be removed from the penetrator assembly and associatedpenetrator.

In various embodiments of the apparatus the handle may be T-shaped,pistol-shaped, round or oval-shaped, an ergonomically designed grip orany other shape suitable for general or specific use. In variousembodiments the handle may include a compartment for enclosing aninterosseous needle, a penetrator and associated trocar or any otheraccessory suitable for use with the apparatus.

In another embodiment a power driven apparatus for penetrating bonemarrow of a bone may be provided. The apparatus may include a housing, amotor, a gear assembly, at least one drive shaft and a power source, andat least one drive shaft operable to connect to an auxiliary device andfurther operable to provide rotational energy to the auxiliary device.In various embodiments the auxiliary devices may include a ring cutter,a suction machine, or a flashlight.

Apparatus and methods incorporating teachings of the present inventionmay be used to access the bone marrow of any bone in a human or animal'sbody for any purpose including the delivery of fluids, medications,drugs, chemicals and any other bioactive substances including blood.Teachings of the present invention may also be used for harvesting bonemarrow and/or stem cell. Teachings of the present invention may also beused to access body tissue or body cavities other than bone marrow in ahuman or animal species.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of the present embodimentsand advantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A shows an example illustration of an apparatus operable forpenetrating bone marrow of a bone;

FIG. 1B is a schematic drawing showing an exploded view of the apparatusin FIG. 1A;

FIG. 1C is a schematic drawing showing an end view of the apparatus inFIG. 1A;

FIG. 1D is a schematic drawing showing one example of driver andconnector incorporating teachings of the present invention;

FIG. 1E is a schematic drawing showing an example of a penetratorassembly which may be releasably engaged with a handle in accordancewith teachings of the present invention;

FIG. 1F is a schematic drawing in section with portions broken awayshowing an exploded view of a penetrator assembly having an outerpenetrator and an inner penetrator which may be releasably engaged witha handle in accordance with teachings of the present invention;

FIG. 1G is a schematic drawing showing an enlarged view of a tip formedon an inner penetrator which may be in accordance with teachings of thepresent invention;

FIG. 1H is a schematic drawing showing an enlarged view of a tip formedon an outer penetrator in accordance with teachings of the presentinvention;

FIG. 1I is a schematic drawing in section and in elevation with portionsbroken away showing one example of an apparatus communicating with bonemarrow of a bone in accordance with teachings of the present invention;

FIG. 2 shows an example illustration of an apparatus for penetratingbone marrow of a bone in accordance with teachings of the presentinvention;

FIG. 3A shows an example illustration of an apparatus operable forpenetrating bone marrow of a bone in accordance with teachings of thepresent invention;

FIG. 3B shows an example illustration of an apparatus operable forpenetrating bone marrow of a bone in accordance with teachings of thepresent invention;

FIG. 3C shows an example illustration of an apparatus operable forpenetrating bone marrow of a bone in accordance with teachings of thepresent invention;

FIG. 3D is a schematic drawing showing an isometric view of a containeroperable to enclose a penetrator assembly in accordance with teachingsof the present invention;

FIG. 4A shows another example illustration of an apparatus forpenetrating bone marrow of a bone in accordance with teachings of thepresent invention;

FIG. 4B is a schematic drawing in section with portions broken awayshowing one example of a penetrator assembly which may be releasablyengaged with a drive shaft in accordance with teachings of the presentinvention;

FIG. 4C is a schematic drawing in section with portions broken awayshowing another example of an opening formed in a penetrator assemblywhich may be releasably engaged with a drive shaft in accordance withteachings of the present invention;

FIG. 4D is a schematic drawing in section with portions broken awayshowing still another example of an opening formed in a penetratorassembly which may be releasably engaged with a drive shaft inaccordance with teachings of the present invention;

FIG. 5A shows an example illustration of an auxiliary device which maybe modified for use with apparatus operable for penetrating bone marrowof a bone in accordance with teachings of the present invention;

FIG. 5B shows an example illustration of a power driven apparatusoperable for penetrating bone marrow of a bone and compatible withoperating an auxiliary device; and

FIG. 6A is a schematic drawing showing an exploded view of anotherexample of apparatus operable for penetrating bone marrow of a bone inaccordance with the teachings of the present invention;

FIG. 6B is a schematic drawing showing still another example of anapparatus operable for penetrating bone marrow of a bone in accordancewith teachings of the present invention; and

FIG. 7 is a schematic, exploded drawing showing one example of fittingsatisfactory for attachment of tubing with a hub and penetrator inaccordance with teachings of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Some preferred embodiments of the invention and its advantages are bestunderstood by reference to FIGS. 1A-7 wherein like numbers refer to sameand like parts.

Various aspects of the present invention may be described with respectto treating human patients. However, apparatus and methods incorporatingteachings of the present invention may be used to treat veterinarypatients as well.

There are times when availability or advisability of having a batterypowered driver for interosseous (IO) access is not possible. Suchconditions may involve military special operations where extremetemperatures and severe weight restrictions limit what can be carriedinto battle. The same may be true for civilian emergency medicalservices (EMS) or first responders where long shelf life and infrequentuse make the convenience of a battery powered driver impractical. Forthis reason, a manual driver offers certain advantages over a batterypowered driver. Establishing interosseous access with a manual drivermay sometimes take longer than with a powered driver. However, a bonemay be penetrated and associated bone marrow accessed using eitherdriver. When a manual driver is used, manual force may be exerted on ahandle or grip to insert a penetrator or needle into the bone to accessthe bone marrow. A manual driver may also serve as a useful backup incases where a battery powered driver fails to function, for example, dueto a depleted power supply.

FIGS. 1A, 1B and 1C show one embodiment of manual driver 10 a whereinhandle 12 a includes drive shaft 16 a. Manual driver 10 a may alsoinclude an optional ratchet mechanism such as shown in FIG. 3A. Handle12 a may be formed in a variety of shapes, such as with fingergrips 20.Handle 12 a may be formed from materials satisfactory for multiple usesor may be formed from materials satisfactory for one time or disposableuse. T-shaped handle 12 e (See FIG. 3C), substantially round or ovalshaped handle 12 a (See FIGS. 1A and 1B), pistol-grip handle 12 b (SeeFIG. 2) or any other ergonomically designed shape suitable for graspingwith the hand or fingers during manual insertion of a penetrator may beused.

Various techniques may be satisfactorily used to releasably engage orattach a handle with an associated connector and/or penetrator inaccordance with teachings of the present invention. For someapplications a handle and an associated connector may be formed as asingle unit. See FIGS. 6A and 6B. In such a configuration thehandle/connector combination is operable to attach to a hub of a tissuepenetrator. The handle and connector may or may not be detachable fromeach other. For other applications, a handle may be releasably engagedto a hub and associated penetrator without the use of a connector.

FIG. 1B shows apparatus 10 a with the components separated. Handle 12 aincludes optional finger grips or finger rests 20. Drive shaft orattachment 16 a may be releasably engaged with end 181 of connector 180.Inner penetrator or trocar 220 extends from end 182 of connector 180.Connector 180 and attached inner penetrator 220 may be releasablyengaged with each other by Luer type fittings, threaded connections orother suitable fittings formed on first end 201 of hub 200. Outerpenetrator 210 extends from second end 202 of hub 200.

FIG. 1C shows an end on view of apparatus 10 a.

FIG. 1D opening 186 may be formed in first end 181 to receive associateddrive shaft 16 a. See FIG. 1D. Opening 186 may be formed with variousconfigurations and/or dimensions. For some applications opening 186 mayinclude a passageway or channel sized to receive portions of drive shaft16 a. One or more webs 136 may be formed in end 181 extending fromopening 186. Open segments or void spaces 138 may be formed between webs136. Respective projections 146 extending from adjacent portions ofhandle 12 a may be releasably engaged with webs 136 and void spaces 138.Opening 186 and associated web 136 may be used to releasably coupleconnector 180 with either a manual driver or a powered driver. Anexample of a powered driver is shown in FIG. 5B.

FIG. 1E shows an enlarged view of penetrator assembly 160.

As shown in FIG. 1F, penetrator assembly 160 may include connector 180,hub and associated hub 200, outer penetrator 210 and inner penetrator220. Penetrator assembly 160 may include an outer penetrator such as acannula, hollow tube or hollow drill bit and an inner penetrator such asa stylet or trocar. Various types of stylets and/or trocars may bedisposed within an outer penetrator. For some applications outerpenetrator or cannula 210 may be described as a generally elongated tubesized to receive inner penetrator or stylet 220 therein. Portions ofinner penetrator 220 may be disposed within longitudinal passageway 184extending through outer penetrator 210. The outside diameter of innerpenetrator 220 and the inside diameter of longitudinal passageway 184may be selected such that inner penetrator 220 may be slidably disposedwithin outer penetrator 210.

Metal disc 70 may be disposed within opening 186 for use in releasablyattaching connector 180 with a magnetic drive shaft. For someapplications, drive shaft 16 a may be magnetized. End 223 of innerpenetrator 220 is preferably spaced from metal disc 70 with insulatingor electrically nonconductive material disposed therebetween.

Tip 211 of outer penetrator 210 and/or tip 222 of inner penetrator 220may be operable to penetrate bone and associated bone marrow. Theconfiguration of tips 211 and/or 222 may be selected to penetrate a boneor other body cavities with minimal trauma. First end or tip 222 ofinner penetrator 220 may be trapezoid shaped and may include one or morecutting surfaces. In one embodiment outer penetrator 210 and innerpenetrator 220 may be ground together as one unit during an associatedmanufacturing process. Providing a matching fit allows respective tips211 and 222 to act as a single drilling unit which facilitates insertionand minimizes damage as portions of penetrator assembly 160 are insertedinto a bone and associated bone marrow. Inner penetrator 220 may alsoinclude a longitudinal groove (not expressly shown) that runs along theside of inner penetrator 220 to allow bone chips and/or tissues to exitan insertion site as penetrator assembly 160 is drilled deeper into anassociated bone. Outer penetrator 210 may be formed from stainlesssteel, titanium or other materials of suitable strength and durabilityto penetrate bone.

Hub 200 may be used to stabilize penetrator assembly 160 duringinsertion of an associated penetrator into a patient's skin, soft tissueand adjacent bone at a selected insertion site. First end 201 of hub 200may be operable for releasable engagement or attachment with associatedconnector 180. Second end 202 of hub 200 may have a size andconfiguration compatible with an associated insertion site for outerpenetrator 210. The combination of hub 200 with outer penetrator 210 maysometimes be referred to as a “penetrator set” or intraosseous needle.

For some applications connector 180 may be described as a generallycylindrical tube defined in part by first end 181 and second end 182.The exterior of connector 180 may include an enlarged tapered portionadjacent to end 181. A plurality of longitudinal ridges 190 may beformed on the exterior of connector 180 to allow an operator to graspassociated penetrator assembly 160 during attachment with a drive shaft.See FIG. 1E. Longitudinal ridges 190 also allow connector 180 to begrasped for disengagement from hub 200 when outer penetrator 210 hasbeen inserted into a bone and associated bone marrow.

Second end 182 of connector 180 may include opening 185 sized to receivefirst end 201 of hub 200 therein. Threads 188 may be formed in opening185 adjacent to second end 182 of connector 180. Threaded fitting 188may be used in releasably attaching connector 180 with threaded fitting208 adjacent to first end 201 of hub 200.

First end 201 of hub 200 may include a threaded connector 208 or othersuitable fittings formed on the exterior thereof. First end 201 may havea generally cylindrical pin type configuration compatible withreleasably engaging second end or box end 182 of connector 180.

For some applications end 202 of hub 200 may have the generalconfiguration of flange. Angular slot or groove 204 sized to receive oneend of protective cover or needle cap 234 may be formed in end 202. Slotor groove 204 may be used to releasable engage cover 234 with penetratorassembly 160. See FIGS. 1A, 1E and 2. For some applications cover 234may be described as a generally hollow tube having rounded end 232.Cover 234 may be disposed within associated slot 204 to protect portionsof outer penetrator 210 and inner penetrator 220 prior to attachmentwith an associated handle. Cover 234 may include a plurality oflongitudinal ridges 236 formed on the exterior thereof. Longitudinalridges 236 cooperate with each other to allow installing and removingcover or needle cap 234 without contaminating portions of an associatedpenetrator. Cover 234 may be formed from various plastics and/or metals.

The dimensions and configuration of second end 202 of hub 200 may bevaried to accommodate various insertion sites and/or patients. Hub 200may be satisfactorily used with a wide variety of flanges or otherconfigurations compatible for contacting a patient's skin. Also, end 202and associated flange may be used with a wide variety of hubs. Thepresent invention is not limited to hub 200, end 202 or the associatedflange. Passageway 206 may extend from first end 201 through second end202. The inside diameter of passageway 206 may be selected to securelyengage the outside diameter of penetrator 210. The dimensions andconfiguration of passageway 206 may be selected to maintain anassociated penetrator assembly engaged with hub 200.

FIG. 1G shows an enlarged view of tip 222 formed on the end of innerpenetrator 220 disposed within outer penetrator 210. FIG. 1H shows anenlarged view of tip 211 formed on the end of outer penetrator 210.

In one embodiment of the invention steps for penetrating into bonemarrow may include turning or rotating a drive shaft to insertpenetrator 24 (See FIG. 4A), penetrator 110 (See FIG. 4B) or penetrator210 (See FIG. 1A-1B) into a bone and associated bone marrow usingrotational motion, disengaging an associated drive shaft from connector80 or 180 and disengaging connector 80 or 180 from associated hub 100 or200 leaving hub 100 or 200 and attached penetrator 24, penetrator 110 orpenetrator 210 disposed in the bone marrow. The depth of penetrationinto a bone and associated bone marrow may be determined by the distancebetween second end 102 of hub 100 and the extreme end of tip 30 or tip111 or the distance between second end 202 of hub 200 and the extremeend of tip 211. For some applications, threaded connection or fittings108 or 208 may allow attachment with various types of Luer locks and/orLuer fittings associated with of intravenous tubing or a syringe withfirst end 101 of hub 100 or first end 201 of hub 200.

FIG. 1I shows outer penetrator or cannula 110 inserted into bone 130 andassociated bone marrow 140. Various types of connections may be used tocommunicate fluids to bone marrow 140 via outer penetrator 210 may thenbe used to connect intravenous tubing 150 to outer penetrator 210. Rightangle connector 132 has the advantage of allowing tubing 150 to beconnected to outer penetrator 110 at an angle that will not kink orpinch off the lumen of tubing 150. Lock nut 133 may be used to engageright angle connector 132 with hub 200.

FIG. 1I illustrates only one example of a connector that may be used tocommunicate fluids between outer penetrator 110 and tubing 150.Intravenous tubing may be used to provide intravenous fluids and/ormedications to associated bone marrow. The tubing may also be used inwithdrawing a sample of blood from the bone marrow. Other connectors oradapters may also be used to connect a penetrator to an intravenoustubing, other types of tubing and/or a syringe. See FIG. 7.

Apparatus formed in accordance with teachings of the present inventionmay have ergonomic designs that allow insertion pressure or forces, forexample, manual force, to be applied with relative ease and at the sametime permit rotation action of an associated handle. In FIG. 3C driveshaft 16 with associated handle 12 e may be aligned with an anatomicallyneutral position of an operator's hand and wrist as it pronates andsuppinates. This alignment may allow better axial orientation of apenetrator assembly as an associated penetrator is inserted into a boneand associated bone marrow with less chance of excessive movement and/ormisalignment of the penetrator which might result in undesired wideningand/or elongation of an associated insertion hole. Insertion forces arenot limited to rotation but may include reciprocal or direct axialforces applied by manual force.

FIG. 2 shows another example of apparatus which may be used to insert apenetrator into bone marrow in accordance with teachings of the presentinvention. FIG. 2 shows manual driver 10 b wherein handle 12 b includesdrive shaft 16 b. Manual driver 10 b may also include an optionalratchet mechanism such as shown in FIG. 3A. Handle 12 b may bereleasably engaged with penetrator assembly 160 and for any otherpenetrator assembly incorporating teachings of the present invention.

Apparatus 10 c as shown in FIG. 3A may also include first drive shaft 16a and second drive shaft 16 c. Drive shafts 16 a and 16 c may includerespective ratchet mechanisms 14. Drive shaft 16 a and 16 c may bedisposed at different angles with respect to handle 12 c to accommodatedifferent insertion sites for an associated penetrator assembly and/orto accommodate different types of penetrator assemblies. Drive shafts 16a and 16 c may have the same round shaped cross section or may havedifferent cross sections.

For embodiments of the present invention such as shown in FIG. 3A,apparatus 10 c may include handle 12 c having at least one chamber 40disposed therein. The configuration and size of chamber 40 (as shown indotted lines in FIG. 3A) may be selected to accommodate one or morepenetrator assemblies and/or other devices. Cap 42 may be secured on oneend of handle 12 c to retain a penetrator assembly or other devicewithin chamber 40.

As discussed later in more detail, penetrator assemblies are preferablydisposed within a sealed container prior to use. An example of onecontainer incorporating teachings of the present invention is shown inFIG. 3D. Penetrator assembly 160 is shown in dotted lines in chamber 40to indicate that various items other than container 43 may besatisfactorily disposed within a handle in accordance with teachings ofthe present invention. Chamber 40 may be configured to accommodate oneor more containers 43 and/or multiple devices.

Apparatus 10 d as shown in FIG. 3B may include handle 12 d having amodified configuration as compared to previously described handles.Drive shaft 16 b may have four sides which define a generally square orrectangular cross section. Drive shaft 16 b may also have five (5)sides, six (6) sides or a key shape. Handle 12 d also includes chamber40 with container 43 disposed therein. As previously noted, apparatus 10e as shown in FIG. 3C may include generally T-shaped handle 12 e.

As shown in FIG. 3D, container 43 includes an attached lid 44. Lid 44includes tab 46 configured to be flipped open with one or more digits ofthe hand. Lid 44 of container 43 may be opened with one hand of anoperator. With lid 44 open, an operator may engage a penetrator assemblywith a drive shaft of either a manual or powered driver held in theother hand of the operator. Flexible strap 48 may be used to releasablyengage lid 44 with container 43. A container incorporating teachings ofthe present invention allows a penetrator assembly to be retained in asterile environment. When use of the penetrator assembly is required, amanual or powered driver may be engaged with a penetrator assemblyincorporating teachings of the present invention without contaminatingthe penetrator assembly. As discussed later in more detail variousmechanisms such as magnets, o-rings and/or ball detents may besatisfactorily used to allow releasable engagement of a drive shaft witha penetrator assembly.

Ratchet mechanism 14 (See FIGS. 3A, 3B and 3C) is an optional componentthat may be included in some embodiments to provide additional leveragefor insertion of an associated penetrator. For example, a ratchet mayfunction by engaging a connector attached to a hub of a needle assemblywhen rotational power is applied in a clockwise direction. Ratchetmechanism 14 may be reversible such that an associated handle may berotated in either a clockwise or counterclockwise direction. Apparatusincorporating teachings of the present invention may include a rotatablecollar (not expressly shown) configured to lock and unlock a reversibleratchet mechanism in order to change the direction of rotation. Driveshafts incorporating teachings of the present invention may be connectedto ratchet mechanism 14 to apply rotational force in only one direction.Ratchet mechanism 14 may be a “silent” type, including three ballbearings (not expressly shown) configured to produce a desired effectwithout accompanying noise produced by a conventional ratchet. Driveshafts may also be attached to handle incorporating teachings of thepresent invention (not expressly shown) without the use of ratchetmechanism 14.

Various types of penetrators and penetrator assemblies may besatisfactorily used with a handle incorporating teachings of the presentinvention. Examples of such penetrators and penetrator assembliesinclude, but are not limited to, penetrator assembly 22 as shown in FIG.1A, penetrator assembly 22 as shown in FIG. 4A and penetrator assembly60 as shown in FIG. 4B. For some applications penetrator assembly 22 mayinclude connector 80, hub 100 and penetrator 24 as shown in FIG. 4A. Forsome applications penetrator assembly 60 may include connector 80, hub100, cannula 110 and trocar 120 as shown in FIG. 43. For someapplications penetrator assembly 160 may include connector 180, hub 200,cannula 210 and trocar or stylet 220 as shown in FIG. 1A. Apparatus andmethods incorporating teachings of the present invention may be usedwith a wide variety of handles, connectors, hubs and penetrators. Thepresent invention is not limited to handles, connectors, flanges,penetrators and/or penetrator assemblies as shown in FIGS. 1A-6B. Forsome applications a handle or driver may be directly attached to apenetrator hub without the use of a connector.

For some applications a penetrator assembly may include only a single,hollow penetrator. For other applications a penetrator assembly mayinclude an outer penetrator such as a cannula, hollow needle or hollowdrill bit and an inner penetrator such as a stylet, trocar or otherremovable device disposed within the outer penetrator. Penetrator 24 isone example of a single, hollow penetrator. See FIG. 4A. Penetrator 24may include one or more side posts (not expressly shown.) Cannulas 110and 210 are examples of outer penetrators. Trocar 120 and stylet 220 areexamples of an inner penetrator. See FIGS. 1B and 1E.

The size of a penetrator may vary depending upon the intendedapplication for the associated penetrator assembly. Penetrators may berelatively small for pediatric patients, medium size for adults andlarge for oversize adults. By way of example, a penetrator may range inlength from five (5) mm to thirty (30) mm. The diameter of a penetratormay range from eighteen (18) gauge to ten (10) gauge. The length anddiameter of the penetrator used in a particular application may dependon the size of a bone to which the apparatus may be applied. Penetratorsmay be provided in a wide variety of configurations depending uponintended clinical purposes for insertion of the associated penetrator.For example, there may be one configuration for administering drugsand/or fluids to a patient's bone marrow and an alternativeconfiguration for sampling bone marrow and/or blood from a patient.Other configurations may be appropriate for bone and/or tissue biopsy.Some penetrators may be suitable for more than one purpose. Theconfiguration and size of a penetrator may also vary depending upon thesite chosen for insertion of each penetrator.

As shown in FIG. 4A, penetrator assembly 22 may include connector 80,hub and associated flange 100 and penetrator 24. For some applicationspenetrator 24 may be generally described as a hollow needle satisfactoryfor communicating fluids with bone marrow. Penetrator 24 may beconfigured to penetrate bone, bone marrow, or other tissues or cavitiesof a body. Various types of intraosseous needles and/or hollow drillbits may be used as penetrator 24. Tip 30 of penetrator 24 may besatisfactory for use in drilling a hole in a bone in response torotation of handle 22. An opening (not expressly shown) may be formed inpenetrator 24 approximate tip 30 to allow communication of fluidsbetween a fluid flow passage (not expressly shown) formed in penetrator24 and adjacent bone marrow.

As shown in FIGS. 4A and 4B, hub 100 may be used to stabilize apenetrator assembly during insertion of an associated penetrator througha patient's skin, soft tissue and adjacent bone at a selected insertionsite. First end 101 of hub 100 may be operable for releasable engagementor attachment with associated connector 80. Second end 102 andassociated flange of hub 100 may have a size and configurationcompatible with an associated insertion site for penetrator 24. Thecombination of hub 100 with penetrator 24 may sometimes be referred toas “a penetrator set or assembly.”

Various techniques may be satisfactorily used to releasably engageconnector 80 with hub 100 and penetrator 24. For example, various typesof mechanical fasteners including, but not limited to, mechanicalfittings and threaded connections and/or Luer lock nuts may besatisfactorily used to releasably engage a handle with a penetrator inaccordance with teachings of the present invention.

For some applications, connector 80 may be described as a generallycylindrical rod defined in part by first end 81 and second end 82.Longitudinal passageway 84 may extend from first end 81 through aportion of connector 80. For embodiments such as shown in FIG. 4Bpassage 84 preferably terminates prior to disc 70. For some applicationslongitudinal passageway 84 may be sized to receive a stylet or trocar.See FIG. 4B. For other applications connector 80 may be satisfactorilyused without longitudinal passageway 84.

An enlarged opening may be formed in first end 81 to receive drive shaft16. Threaded fitting 88 may be formed adjacent to second end 82 ofconnector 80 for use in releasably attaching connector 80 with first end101 of hub 100. For some applications a plurality of ridges orindentations 90 may be formed on the exterior of connector 80 to allowan operator to grasp penetrator assembly 22 during attachment with driveshaft 16. Ridges or indentations 90 also allow connector 80 to begrasped for disengagement from hub 100 when penetrator 24 has beeninserted into a bone and associated bone marrow.

For some applications end 102 of hub 100 may include an annular slot orgroove 104 sized to receive one end of protective cover 32. Slot orgroove 104 may be used to releasably engage cover 32 with penetratorassembly 22 and/or penetrator assembly 60. See FIG. 4B. For someapplications cover 32 may be described as a generally hollow tube havingrounded end 34. Cover 32 may be disposed within associated slot 104 toprotect portions of a penetrator prior to attachment with a manual orpower driver. Cover 32 may be formed from various plastics and/or metalsand may be employed with alternate penetrator assembly embodiments.

The dimensions and configuration of second end 102 of hub 100 may bevaried to accommodate various insertion sites and/or patients.Passageway 106 may extend from first end 101 through hub 100 to secondend 102. The inside diameter of passageway 106 may be selected tosecurely engage the outside diameter of penetrator 24 and/or the outsidediameter of cannula 110. The dimensions and configuration of passageway106 may be selected to maintain an associated penetrator securelyengaged with hub 100. Several techniques and methods may be used tosecure a penetrator with a hub including, but not limited to, knurling,shot peening, flanges (not expressly shown) glue and/or serrations.

First end 101 of hub 100 may include threaded connection 108 or othersuitable fitting on the exterior thereof. First end 101 may have agenerally cylindrical pin type configuration compatible with releasablyengaging second end or box end 82 of connector 80. Threaded connection88 may be releasably engaged with threads 108.

Connectors 80, 80 b, 80 c and 80 d may have similar exteriorconfigurations and dimensions as respectively shown in FIGS. 4A, 4B, 4Cand 4D. However, the dimensions and configurations of connectorsincorporating teachings of the present invention may be substantiallymodified as compared to connectors 80, 80 b, 80 c and 80 d.

Opening 86 in each connector 80 may have various configurations anddimensions for releasable engagement with an associated drive shaft. Forsome applications a drive shaft may have four sides, five sides, sixsides, or eight sides. A drive shaft may also have a “D shaped” crosssection. The drive shaft may also be round or any other keyedconfiguration. Drive shafts and associated openings in a connector maybe tapered relative to each other (not expressly shown).

Drive shaft 16 as shown in FIG. 4A may have five sides. Correspondingopening 86 b as shown in FIG. 4B may also include five sides compatiblewith releasably receiving drive shaft 16. For some applications,metallic disc 70 may be disposed within opening 86 b opposite from end81. Metallic disc 70 may be satisfactorily used to releasably engagepenetrator assembly 60 as shown in FIG. 4B with a drive shaft formedfrom materials which are magnetized. Drive shaft 16 may include orincorporate a magnet configured to releasably engage metallic disc 70disposed within penetrator assembly 60. Cooperation between metallicdisc 70 and magnetized drive shaft 16 allows removing a penetratorassembly from a container such as container 43.

For other applications one or more magnets 72 and 74 may be disposedwithin the sides of opening 86 to releasably engage an associated driveshaft with connector 80 b. Magnets 72 and 74 are shown in dotted linesin FIG. 1B. Magnets 72 and/or 74 may be used to releasably engage aconnector with a drive shaft formed from appropriate metal alloys orother materials.

For embodiments of the present invention such as shown in FIG. 4C,opening 86 c may have a generally circular shaped cross section. O-ring96 may be disposed within opening 86 c of connector 80 c. O-ring 96 mayform a satisfactory engagement with an associated drive shaft having acorresponding generally circular cross section. Drive shafts 16 a and 16c as shown in FIG. 3A may have a generally circular cross section.

Connector 80 d as shown in FIG. 4D may include ball 96 and spring 98which engage a corresponding detent or recess (not expressly shown) in adrive shaft. Ball detent mechanism 96 and spring 98 may cooperate witheach other to releasably engage connector 80 d and associated penetratorassembly with a drive shaft. Other mechanisms may also be satisfactorilyused to releasably engage a drive shaft with a connector in accordancewith teachings of the present invention. Such mechanisms include but arenot limited to snap ring connectors (not expressly shown), lock and keyconnectors (not expressly shown), and similar releasable connections.

For embodiments such as shown in FIG. 4B, various types of threadedconnections or other suitable fittings may be used. End 82 of connector80 preferably includes an enlarged opening or passageway sized toreceive first end 101 of hub 100. Threads 88 formed within end 82 may bereleasably engaged with threads 108 formed on the exterior of end 101.

For embodiments of the present invention such as shown in FIG. 4B,penetrator assembly 60 may include an outer penetrator such as acannula, hollow needle or hollow drill bit and an inner penetrator suchas a stylet or trocar. Various types of stylets and/or trocars may bedisposed within an outer penetrator. For some applications, outerpenetrator or cannula 110 may be described as having a generallyelongated, hollow tube sized to receive inner penetrator or trocar 120therein. Portions of trocar 120 may be disposed within longitudinalpassageway 84 extending through connector 80. The outside diameter oftrocar 120 and the inside diameter of longitudinal passageway 84 may beselected such that trocar 120 may be securely engaged with connector 80.For some applications, metallic disk 70 may be disposed within opening86 adjacent to trocar 120.

Tip 111 of outer penetrator 110 and/or tip 112 of inner penetrator 120may be operable to penetrate bone and associated bone marrow. Theconfiguration of tips 111 and/or 121 may be selected to penetrate a boneor other body cavities with minimal trauma. First end or tip 121 oftrocar 120 may include one or more cutting surfaces. In one embodimentouter penetrator 110 and inner penetrator 120 may be ground separatelyduring the manufacturing process and later aligned to ensure an exactfit to allow respective tips 111 and 121 act as a single drilling unitto facilitate insertion and minimize damage as portions of penetratorassembly 60 are inserted into a bone and associated marrow. Theresulting configuration of tips 111 and 121 may be formed to penetrate abone or other body cavities with minimal trauma.

Inner penetrator 120 may also include a longitudinal groove (notexpressly shown) that runs along the side of inner penetrator 120 toallow bone chips and/or tissue to exit an insertion site as penetratorassembly 60 is drilled deeper into an associated bone. Cannula 110 maybe formed from stainless steel, titanium or other materials of suitablestrength and durability to penetrate bone.

A wide variety of accessory tools and devices are frequently carried byemergency medical service personnel and/or first responders. Ring cutter50 as shown in FIG. 5A may be representative of such accessory tools.Ring cutter 50 may include thumb lever 52 and finger protector 54. Ringcutting blade 56 may be rotatably mounted on arm 58 extending fromhandle 12 f.

For some applications, ring cutting blade 56 may be engaged with a hubincorporating teachings of the present invention. For example, ringcutting blade 56 may be securely engaged with hub 100 b such as shown inFIG. 5B. First end 101 of hub 110 b may be modified to have opening 86 bsimilar to opening 86 b as described with respect to connector 80 b. Forsome applications, handles 12, 12 a, 12 b, 12 c, 12 d and/or 12 e may bereleasably engaged with hub or hub 100 b for use in rotating ringcutting blade 56. For other applications, power driven driver 312 may beattached with hub or hub 100 b. Driver 312 may include electrical motor314 coupled with drive shaft 300. Batteries or power supply 318 may bedisposed within powered driver 312. Trigger 320 may be used to activatemotor 314.

Examples of power drivers which may be used with a hub or flange areshown in U.S. Pat. No. 6,183,442 entitled “Tissue Penetrating Device andMethods of Using Same” and U.S. Pat. No. 5,554,154 entitled“Intra-Osseous Needle Drill.” Power drivers are also shown in pendingU.S. patent application Ser. No. 10/449,503 entitled “Apparatus andMethod to Provide Emergency Access to Bone Marrow” filed May 30, 2003and Ser. No. 10/449,476 entitled “Apparatus and Method to Access BoneMarrow” filed May 30, 2003.

Having a reliable powered driver may be of benefit to an operator inother situations requiring rotational forces or power. For example,drive shaft 300 may be mated to a variety of auxiliary devices that maybe powered by rotational or reciprocal motion. Other examples ofaccessory or auxiliary devices (not expressly shown) which may beattached with a handle in accordance with teachings of the presentinvention include, but are not limited to, orthopedic fixation devices,portable suction devices, flashlights or any other medical or fielddevice that uses a power source. Flashlight attachments to either amanual or powered driver may include a red light for night visionpurposes or a white light (not expressly shown). Such lights may be ofthe LED type.

FIGS. 1A, 2, 3A-3C, 6A and 6B and 1B show embodiments of the presentinvention which include a manual driver which may be releasably engagedwith a hub in accordance with the teachings of the present invention.Apparatus 10 f as shown in FIG. 6A may include handle 12 f withconnector 280 formed as an integral component thereof. Various types ofthreaded connections and/or other fittings may be satisfactorily used toreleasably engage driver 10 f with hub 200. For some applications,threaded connection 188 may be formed within connector 280 forreleasable engagement with threaded connection 208 formed on hub 200. InFIG. 6A, apparatus 10 f may include penetrator or trocar 220 extendingfrom handle 12 f.

FIG. 6B shows apparatus 10 g which includes handle 12 g and hub 200. Forembodiments of the present invention such as shown in FIG. 6B, apparatus10 g does not include a penetrator or trocar. Hub 200 may includepreviously described penetrator 24 with sideport or opening 26 formedtherein.

FIG. 7 is a schematic drawing showing one example of a Luer type fittingor Luer type connection which may be satisfactorily formed between hub200 and an intravenous tubing 150. Male fitting 40 may be inserted intoone end of tubing 150. Male fitting 40 preferably includes taperedsurface 62 designed to form a fluid tight seal with tapered surface 64formed with hub 200 adjacent to end 210. Tapered surfaces 62 and 64cooperate with each to form portions of a fluid tight Luer fitting orconnection. Luer locking nut or luer collar 133 may be used to securelyengage tapered surface 62 and 64 with each other. Luer locking nut 133may be securely engaged with threads 208 formed on the exterior of hub200 adjacent to end 201. After hub 200 and associated penetrator 210have been disposed at a selected insertion site, male type Luer fitting36 may be slideably disposed in female type Luer fitting 38. Luerfittings 36 and 38 preferably have tapered surfaces which engage witheach other to form a substantially fluid tight seal between each other.Luer lock 133 may be used to securely engage to retain secure engagementbetween Luer fittings 36 and 38.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalternations can be made herein without departing from the spirit andscope of the invention as defined by the following claims.

1. An apparatus for penetrating the bone marrow of a bone comprising: ahandle comprising a drive shaft; a connector comprising a first endoperable to connect to the drive shaft and a second end operable toattach to a penetrator hub; and the penetrator hub comprising apenetrator operable to access the bone marrow.
 2. The apparatus of claim1, the handle selected from a group consisting of T-shaped,substantially round-shaped, substantially oval-shaped, grip-shaped andsubstantially ergonomic-shaped.
 3. The apparatus of claim 1 wherein thedrive shaft comprises a ratchet.
 4. The apparatus of claim 1 wherein theconnector is selected from a group consisting of a magnet, an O-ringmechanism and a ball and detent mechanism.
 5. The apparatus of claim 1wherein a second end of the connector comprises a threaded connection.6. The apparatus of claim 1 wherein the hub comprises a threadedconnection.
 7. The apparatus of claim 1 wherein the penetrator comprisesa hollow channel and a tip having one or more cutting surfaces.
 8. Theapparatus of claim 1 wherein the connector is releasably attached to thedrive shaft.
 9. The apparatus of claim 1 wherein the handle comprises atleast one storage compartment.
 10. The apparatus of claim 1 wherein thehandle comprises at least one drive shaft.
 11. The apparatus of claim 1wherein the connector comprises a trocar.
 12. An apparatus forpenetrating bone marrow of a bone comprising: a handle comprising atleast one drive shaft; a releasable connector comprising a first endoperable to connect to a drive shaft and a second end comprising athreaded connection operable to attach to a penetrator hub; and apenetrator hub comprising a penetrator and a threaded connectionoperable to access the bone marrow.
 13. The apparatus of claim 12wherein the connector is detachable from the hub.
 14. A method ofaccessing bone marrow of a bone comprising: inserting a penetrator,defined in part by an outer cannula and an inner trocar, into the boneand associated bone marrow by a handle rotating a drive shaft and anattached connector; detaching the handle and connector from the hub; andremoving the trocar from the cannula to allow access to the bone marrowthrough the cannula.
 15. An apparatus for penetrating bone marrow of abone comprising: a driver comprising a housing, a motor, a gearassembly, at least one drive shaft and a power source; and at least onedrive shaft operable to connect to an auxiliary device and furtheroperable to provide rotational energy to the device.
 16. The apparatusof claim 15 wherein the power source is selected from a group consistingof a battery pack, electricity, a spring, a gas cartridge and solarpower.
 17. The apparatus of claim 15 wherein the auxiliary device isselected from a group consisting of a ring cutter, a suction device, anda flashlight.
 18. The apparatus of claim 15 wherein the at least onedrive shaft is operable to attach to a connector having a first end anda second end operable to connect to a hub comprising a penetrator. 19.An apparatus for penetrating a bone and providing access to associatedbone marrow comprising: a handle having at least one drive shaftextending therefrom; a connector having a first end operable forreleasable attachment to the drive shaft and a second end operable forreleasable attachment to a penetrator hub; the penetrator hub defined inpart by a flange having a first end and a second end; the first end ofthe hub operable for releasable attachment with the second end of theconnector; a penetrator extending from the second end of the hub and thetip of the penetrator spaced longitudinally from the second end of thehub to accommodate penetration of the bone and associated bone marrow;and the tip of the penetrator operable to penetrate the bone in responseto rotary motion from the handle.
 20. A method of accessing bone marrowof a bone comprising: releasably attaching a connector with a handleoperable to rotate the connector; releasably attaching a penetrator withthe connector; rotating the handle to rotate the connector and thepenetrator to insert the penetrator into the bone and associated bonemarrow; detaching the handle and the connector from the penetrator whenone end of the penetrator is located at a desired position within thebone marrow; and connecting a tubing with the penetrator to communicatefluid between the tubing and the bone marrow.
 21. An container operableto enclose a penetrator assembly for penetrating the bone marrowcomprising: a substantially longitudinal receptacle comprising asubstantially rounded first section operable to accommodate a penetratorassembly and a substantially rounded second section operable toaccommodate an outer penetrator and inner trocar; and a cap including atab operable to be opened with digital pressure.
 22. The container ofclaim 21 wherein the receptacle comprises a seal portion operable toattach to a the cap to prevent contamination of the penetrator assembly.23. A penetrator assembly for penetrating a bone and providing access toassociated bone marrow comprising: an outer hollow penetrator attachedto and extending from a hub; the hub includes one or more indentationssuitable for grasping; and an inner trocar releassably engaged with theouter penetrator.
 24. The apparatus of claim 23 wherein the outer hollowpenetrator comprises a tip with at least one cutting edge operable topenetrate the bone.
 25. The apparatus of claim 23 wherein the outerhollow penetrator comprises a tip with a cutting edge on each of foursides of the penetrator.
 26. The apparatus of claim 23 wherein the innertrocar comprises a tip with a cutting surface on each of two sides ofthe trocar.
 27. The apparatus of claim 23 wherein the penetratorassembly comprises a protective cover having at least one ridge operableto be grasped and removed by an operator.
 28. An apparatus forpenetrating bone marrow of a bone comprising: a handle having a at leastone drive extending therefrom; a penetrator hub operable for releasableattachment with the driver; and the penetrator hub having a penetratoroperable to access the bone marrow.